Fixation of the annular valve within the catheter assembly

Abstract

Fixation of the annular valve within the catheter assembly. [Solution] A catheter system comprising a catheter assembly, the catheter assembly comprising a catheter adapter comprising a terminal end, a proximal end, an inner surface forming a lumen, the lumen extending through the terminal end and the proximal end, a side port disposed between the terminal end and the proximal end, an annular valve disposed in the lumen and aligned with the side port, the annular valve sealing a fluid passage from the side port to the lumen, a retaining ring or protrusion disposed at and near the proximal end of the annular valve in the lumen, and a catheter extending from the terminal end to the terminal end of the catheter adapter.

Description

Background Art

[0001] Background Catheters are commonly used in various infusion therapies. A catheter may be used to inject normal saline, various pharmaceuticals, total parenteral nutrition, or other fluids into a patient. A catheter may also be used to draw blood from a patient for diagnostic or other purposes.

[0002] A common type of catheter is the peripheral intravenous catheter (``PIVC'') that is "over-the-needle". As its name indicates, an over-the-needle PIVC may be placed over an introducer needle having a sharp distal tip. The PIVC and the introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the PIVC and the bevel of the needle faces upward away from the patient's skin. The PIVC and the introducer needle are generally inserted at a shallow angle from the skin into the patient's vascular system.

[0003] To confirm proper placement of the introducer needle and / or the PIVC within the blood vessel, the practitioner generally checks for a "flashback" of blood within the flashback chamber of the catheter assembly. Once the placement of the needle is confirmed, the practitioner may remove the introducer needle while leaving the PIVC in place for future fluid infusion.

[0004] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is provided only to explain an area of technology in which some of the embodiments described herein may be implemented.

[0005] Summary This disclosure relates in general to vascular access devices, systems, and methods. In particular, this disclosure relates to annular valve fixation within a catheter assembly. In some embodiments, the catheter system may include a catheter assembly. In some embodiments, the catheter assembly may include a catheter adapter, which may include a terminal end, a proximal end, an inner surface forming a lumen, the lumen extending through the terminal and proximal ends, and a lateral port positioned between the terminal and proximal ends.

[0006] In some embodiments, the catheter assembly may include an annular valve, which may be located within the lumen and aligned with a side port. In some embodiments, the annular valve may seal a fluid passage from the side port to the lumen. In some embodiments, the catheter assembly may include a retaining ring or protrusion located within the lumen at and / or adjacent to the proximal end of the annular valve. In some embodiments, the catheter assembly may include a catheter extending from the terminal end of the catheter adapter to the terminal end.

[0007] In some embodiments, the inner surface of the catheter adapter may include an undercut. In some embodiments, the retaining ring may be located within the undercut. In some embodiments, the undercut may correspond to a proximal undercut, and the inner surface of the catheter adapter may further include a distal undercut. In some embodiments, the annular valve may be located between the proximal and distal undercuts.

[0008] In some embodiments, the annular valve may contain silicone. In some embodiments, the annular valve may be cylindrical. In some embodiments, the retaining ring may be formed by molding. In some embodiments, the retaining ring may be made of plastic.

[0009] In some embodiments, the catheter system may include a needle assembly. In some embodiments, the needle assembly may include a needle hub and an introduction needle extending terminally from the needle hub through a retaining ring, an annular valve, and a catheter. In some embodiments, a side port may extend from the top of the catheter adapter. In some embodiments, the side port may be configured to receive a syringe. In some embodiments, a retaining ring or protrusion is configured to reduce proximal end movement of the annular valve in response to fluid injection through the side port opening the annular valve.

[0010] In some embodiments, a method for cleaning a catheter assembly may include connecting an infusion device to a side port of the catheter adapter of the catheter assembly. In some embodiments, the method may include activating the infusion device. In some embodiments, in response to activating the infusion device, the annular valve may open to allow fluid to flow from the side port into the lumen. In some embodiments, in response to activating the infusion device, the proximal end of the annular valve may be pressed against a retaining ring, so that the retaining ring is in place. In some embodiments, in response to activating the infusion device, the proximal end of the annular valve may be pressed against a protrusion.

[0011] In some embodiments, the infusion device may include a syringe. In some embodiments, activating the infusion device may include pushing down the plunger of the syringe. In some embodiments, the method may include disconnecting and removing the needle assembly from the catheter adapter. In some embodiments, the infusion device may be activated after the needle assembly has been disconnected and removed from the catheter adapter.

[0012] In some embodiments, the inner surface of the catheter adapter may include a stepped surface. In some embodiments, the stepped surface may include a terminal surface, a proximal surface, and a transition surface located between the terminal and proximal surfaces. In some embodiments, an annular valve located within the lumen may seal the fluid passage from the side port to the lumen. In some embodiments, the annular valve may be in contact with the terminal surface. In some embodiments, the catheter assembly may include a cavity located between the outer surface and the proximal surface of the annular valve. In some embodiments, the transition surface may form the terminal end of the cavity.

[0013] In some embodiments, the transition surface may be located between the terminal end and the proximal end of the annular valve. In some embodiments, the annular valve may be in contact with a portion of the terminal and proximal surfaces. In some embodiments, the annular valve may be in contact with a portion of the proximal surface to form the proximal end of the cavity. In some embodiments, the depth of the cavity may decrease in the proximal direction.

[0014] In some embodiments, the transition surface and the terminal surface may merge at a sharp end. In some embodiments, the stepped surface and cavity may be semi-annular. In some embodiments, in response to injection from a side port, the annular valve may reduce the size of the cavity. In some embodiments, the catheter assembly may include radial vertical ribs extending from the transition surface to the terminal. In some embodiments, the proximal surface may be sandblasted or chemically etched.

[0015] In some embodiments, the stepped surface may correspond to a first stepped surface. In some embodiments, the inner surface of the catheter adapter may include a second stepped surface at its proximal end relative to the first stepped surface. In some embodiments, the catheter assembly may include another cavity positioned between the outer surfaces of the annular valve. In some embodiments, another transitional surface of the second stepped surface may form the terminal end of another cavity.

[0016] It should be understood that both the general description above and the detailed description below are examples and descriptions and do not limit the invention as described in the claims. It should be understood that the various embodiments are not limited to the arrangements and fixtures shown in the drawings. It should also be understood that embodiments may be combined, or other embodiments may be used, and structural modifications may be made without departing from the scope of the various embodiments of the invention unless so claimed. Therefore, the detailed description below should not be taken as limiting.

[0017] A brief explanation of some of the figures in the drawing. Exemplary embodiments will be described and elaborated upon in more specific and detailed terms through the use of the accompanying drawings. [Brief explanation of the drawing]

[0018] [Figure 1] Figure 1 is a cross-sectional view of a prior art catheter system. [Figure 2A] Figure 2A is a cross-sectional view of a catheter system showing an exemplary retaining ring according to several embodiments. [Figure 2B] Figure 2B is an overhead perspective view of a retaining ring according to several embodiments. [Figure 2C] Figure 2C is an enlarged cross-sectional view of a portion of the catheter system shown in Figure 2A, according to several embodiments. [Figure 2D] Figure 2D is a cross-sectional view of the catheter system of Figure 2A, showing an exemplary infusion device coupled to and operated by an exemplary side port, according to several embodiments. [Figure 2E] Figure 2E is a top view of the catheter system of Figure 2A after injection through the side port, according to several embodiments. [Figure 3A] Figure 3A is a cross-sectional view of a catheter system showing an annular valve removed for illustrative purposes, according to several embodiments. [Figure 3B]FIG. 3B is a cross-sectional view of the catheter system of FIG. 3A showing an annular valve prior to fluid injection through a side port, according to some embodiments. [Figure 3C] FIG. 3C is a cross-sectional view of the catheter system of FIG. 3A showing an annular valve opened in response to fluid injection, according to some embodiments. [Figure 3D] FIG. 3D is a cross-sectional view of the catheter system of FIG. 3A cut at the proximal end with respect to an exemplary transition surface, with the annular valve removed for illustrative purposes, according to some embodiments. [Figure 3E] FIG. 3E is a cross-sectional view of the catheter system of FIG. 3A showing two exemplary step surfaces and an annular valve removed for illustrative purposes, according to some embodiments. [Figure 3F] FIG. 3F is an enlarged cross-sectional view of the catheter system of FIG. 3A showing two exemplary step surfaces and an annular valve removed for illustrative purposes. [Figure 3G] FIG. 3G is a cross-sectional view of the catheter system of FIG. 3A showing two step surfaces prior to fluid injection through a side port, according to some embodiments. [Figure 3H] FIG. 3H is a cross-sectional view of the catheter system of FIG. 3A showing two step surfaces and an annular valve opened in response to fluid injection, according to some embodiments. [Figure 3I] FIG. 3I is a cross-sectional view of the catheter system of FIG. 3A showing a plurality of exemplary ribs, according to some embodiments. [Figure 3J] FIG. 3J is an enlarged cross-sectional view of the catheter system of FIG. 3A showing a plurality of exemplary ribs, according to some embodiments. [Figure 3K] FIG. 3K is another cross-sectional view of the catheter system of FIG. 3A, according to some embodiments. [Figure 4A] FIG. 4A is a cross-sectional view of a catheter system showing a plurality of exemplary ridges, according to some embodiments. [Figure 4B]Figure 4B is a cross-sectional view of the catheter system of Figure 4A, showing multiple ridges with the annular valve removed for illustrative purposes, according to several embodiments. [Figure 4C] Figure 4C is a cross-sectional view of the catheter system of Figure 4A, cut immediately to the terminal side in relation to multiple ridges, according to several embodiments. [Figure 5A] Figure 5A is a cross-sectional view of a catheter system showing exemplary proximal and distal undercuts and an annular valve removed for illustrative purposes, according to several embodiments. [Figure 5B] Figure 5B is a cross-sectional view of the catheter system of Figure 5A according to several embodiments. [Modes for carrying out the invention]

[0019] Description of the Embodiment Referring here to Figure 1, a prior art catheter system 10 is shown. The prior art catheter system includes an annular valve 12 located in the lumen 14 of a catheter adapter. The annular valve 12 is often moved proximal to the catheter system 10 in response to fluid injection through a side port 16. Proximal movement of the annular valve 12 may prevent the annular valve 12 from sealing the side port 16, and thus fluid may leak from the catheter adapter lumen 14 through the side port 16 after injection.

[0020] Next, referring to Figures 2A-2C, several embodiments of the catheter system 18 are shown. In some embodiments, the catheter system 18 may include a catheter assembly 20. In some embodiments, the catheter assembly 20 may include a catheter adapter 22, which may include a terminal end 24, a proximal end 26, and an inner surface 28 forming a lumen 30. In some embodiments, the catheter assembly 20 may include a lumen 30 extending through the terminal end 24 and the proximal end 26. In some embodiments, the catheter assembly 20 may include a side port 32 located between the terminal end 24 and the proximal end 26. In some embodiments, the catheter assembly 20 may include a cap 33 detachably coupled to the side port 32.

[0021] In some embodiments, the catheter assembly 20 may include an annular valve 34, which may be located within the lumen 30 and aligned with the side port 32. In some embodiments, the annular valve 34 may seal the fluid passage from the side port 32 to the lumen 30. In some embodiments, the annular valve 34 may be made of silicone or another suitable material, and in response to the injection of fluid through the side port 32, the end of the annular valve 34 may push down and open the fluid passage from the side port 32 to the lumen 30. In some embodiments, the annular valve 34 may be cylindrical.

[0022] In some embodiments, the catheter assembly 20 may include a retaining ring 36 positioned at the proximal end and / or near the annular valve 34 within the lumen 30. In some embodiments, the retaining ring 36 may be in contact with the annular valve 34. In some embodiments, the catheter assembly 20 may include a catheter 38 extending distally from the distal end 24 of the catheter adapter 22. In some embodiments, the catheter 38 may include a peripheral intravenous catheter (PIVC), a midline catheter, a peripherally inserted central catheter, or another suitable type of catheter.

[0023] In some embodiments, the catheter assembly 20 may include a septum 40, which may be positioned at the proximal end relative to the retaining ring 36 and the annular valve 34. In some embodiments, the septum 40 may be made of silicone or other suitable material.

[0024] In some embodiments, the inner surface 28 of the catheter adapter 22 may include an undercut 42, which may be annular. In some embodiments, the retaining ring 36 may be positioned within the undercut 42. In some embodiments, the width 44 of the retaining ring 36 may be approximately equal to the length 46 of the undercut 42, and the end edge 48 and proximal edge 50 of the retaining ring 36 may abut against the edge of the undercut 42. In some embodiments, the end edge 48 and proximal edge 50 may be annular. In some embodiments, the retaining ring 36 may fit snugly within the undercut 42. In some embodiments, the outer diameter may be slightly larger than the diameter of the undercut 42, so that the retaining ring 36 snaps into place within the undercut 42.

[0025] In some embodiments, the retaining ring 36 may be made of plastic, metal, or other suitable material. In some embodiments, the retaining ring 36 may be rigid or semi-rigid. In some embodiments, the durometer of the retaining ring 36 may be greater than the durometer of the annular valve 12. In some embodiments, the retaining ring 36 may be formed by molding. More specifically, in some embodiments, the retaining ring 36 may be formed by molding a liquid or malleable material using a fixed frame such as a mold or matrix. In some embodiments, the mold may include a hollow cavity receptacle into which the liquid or malleable material may be poured. In some embodiments, the liquid or malleable material may include plastic, metal, or other suitable material. The retaining ring 36 is formed when the liquid or malleable material hardens inside the mold.

[0026] In some embodiments, the catheter system 18 may include a needle assembly 52. ​​In some embodiments, the needle assembly 52 may include a needle hub 54 and an introduction needle 56 extending terminally from the needle hub 54 and passing through a retaining ring 36, an annular valve 34, and a catheter 38. In some embodiments, the introduction needle 56 may include a sharp terminal tip, which may facilitate the placement of the catheter 38 in the patient's vascular system.

[0027] In some embodiments, the lateral port 32 may extend from the upper part of the catheter adapter 22 or from a portion of the catheter adapter 22 facing the patient's skin, and may be located below the catheter adapter 22 and / or below one or more wings 58 extending outward from the catheter adapter 22.

[0028] Referring next to Figure 2D, in some embodiments, the side port 32 may be configured to receive an injection device 60, which may include a syringe or other suitable injection device configured to inject fluid into the lumen 30 from the side port 32. In some embodiments, the retaining ring 36 is configured to keep the annular valve 34 in the same or similar position in response to the injection of fluid from the side port 32 opening the annular valve 34. More specifically, in some embodiments, the retaining ring 36 may be configured to reduce the proximal end movement of the annular valve 34 in response to the injection of fluid through the side port 32 opening the annular valve 34. In some embodiments, in response to the injection of fluid through the side port 32 opening the annular valve 34, the proximal end 62 of the annular valve 34 does not need to move in the proximal and / or distal directions. Thus, in some embodiments, the retaining ring 36 may prevent fluid, such as blood and / or another fluid, from leaking through the annular valve 34 from the side port 32.

[0029] In some embodiments, the infusion device 60 may be operated to clean the catheter system 18 or to inject a bolus. In some embodiments, a method for cleaning the catheter assembly 20 may include coupling the infusion device 60 to the side port 32 of the catheter adapter 22 of the catheter assembly 20. In some embodiments, the side port 32 may include a luer, such as a female luer, which may be configured to couple to the corresponding luer of the infusion device 60.

[0030] In some embodiments, the method may include activating the injection device 60. In some embodiments, in response to activating the injection device 60, the annular valve 34 may open to allow fluid to flow from the side port 32 into the lumen 30. In some embodiments, in response to activating the injection device 60, the proximal end 62 of the annular valve 34 opposite to the terminal end 64 may be pressed against the retaining ring 36, and the retaining ring 36 may remain in place. In these and other embodiments, the proximal end 62 of the annular valve 34 may not move in the proximal and / or terminal directions, and may remain in place.

[0031] In some embodiments, the infusion device 60 may include a syringe, for example, as illustrated in Figure 2D. In some embodiments, activating the infusion device 60 may include pushing down the plunger 66 of the syringe, or otherwise causing fluid to be discharged from the infusion device into the catheter assembly 20. In some embodiments, the method may include disconnecting and removing the needle assembly 52 from the catheter adapter 22, for example, as shown in Figure 2D. In some embodiments, the infusion device 60 may be activated after the needle assembly 52 has been disconnected and removed from the catheter adapter 22.

[0032] Next, referring to Figure 2E, the catheter assembly 20 is shown with the cap 33 open after fluid injection through the side port 32. As shown, the annular valve 34 remains in place after fluid injection, sealing the side port 32.

[0033] Next, referring to Figures 3A to 3D, catheter assemblies 68 according to several embodiments are illustrated. In some embodiments, the catheter assembly 68 may be similar to or identical to the catheter assembly 20 described with respect to Figure 2 in terms of one or more features and / or operation. In some embodiments, the inner surface 28 of the catheter adapter 22 may include a stepped surface 70. In some embodiments, the stepped surface 70 may include a proximal surface 72, a terminal surface 74, and a transition surface 76 positioned between the proximal surface 72 and the terminal surface 74. In some embodiments, an annular valve 34 positioned within the lumen 30 may seal the fluid passage from the side port 16 to the lumen 30, for example, as shown in Figure 3B.

[0034] In some embodiments, the annular valve 34 may be in contact with or resting on the terminal surface 74. In some embodiments, the catheter assembly 20 may include a cavity 78 positioned between the outer surface 80 and the proximal surface 72 of the annular valve 12. In some embodiments, the outer surface of the annular valve 12 may be cylindrical as a whole. In some embodiments, the transition surface 76 may form the terminal end of the cavity 78.

[0035] In some embodiments, the transition surface 76 may be located between the terminal end 64 of the annular valve 12 and the proximal end 62 of the annular valve 34. In some embodiments, the annular valve 34 may be in contact with the terminal surface 74 and a portion 80 of the proximal end surface 72, which may be spaced apart from the transition surface 76. In some embodiments, the annular valve 34 may be in contact with the proximal end surface 72 to form the proximal end of the cavity 78. In some embodiments, the depth of the cavity 78 may decrease in the proximal direction, for example, as shown in Figure 3B.

[0036] In some embodiments, the transition surface 76 and the end surface 74 may merge at a sharp edge 82, which may reduce slippage and movement of the annular valve 34. In some embodiments, the stepped surface 70 and / or cavity 78 may be semi-annular or arc-shaped, which may facilitate ejection during demolition. In some embodiments, the stepped surface 70 and / or cavity 78 may be semi-circular.

[0037] In some embodiments, the transition surface 76 may include a shoulder or undercut. In some embodiments, the transition surface 76 may be positioned at approximately 90 degrees with respect to the longitudinal axis 83 of the catheter assembly 68, which may facilitate the formation of the cavity 78. In some embodiments, the transition surface 76 may be positioned at an angle other than 90 degrees with respect to the longitudinal axis of the catheter assembly 10. In some embodiments, the transition surface 76 may be smooth and / or planar. In some embodiments, the transition surface 76 may be uneven, rough, or irregular. In some embodiments, the first transition surface 36 may be curved.

[0038] In some embodiments, the injection of fluid 84 may include flushing the catheter system 18 or injecting a bolus by activating the injection device 60 (see, for example, Figure 2D). In some embodiments, in response to activating the injection device 60, the annular valve 34 may open to allow fluid to flow from the side port 32 into the lumen 30, as illustrated, for example, in Figure 3C.

[0039] In some embodiments, in response to the injection of fluid 84 through the side port 32, the annular valve 34 may reduce the size or volume of the cavity 78, as shown, for example, in Figure 3C. In these embodiments, the annular valve 34 may be forced against the proximal surface 72. In some embodiments, in response to the injection of fluid 84 through the side port 32, the annular valve 34 may clinch to a sharp edge 82 that reduces slippage of the annular valve 34. In some embodiments, the stepped surface 70 and the sharp edge 82 may reduce the movement of the annular valve 34 toward the terminal and / or proximal direction so that the annular valve 34 continues to seal the side port 32 after the injection of fluid 84 is complete.

[0040] In some embodiments, the cavity 78 may be empty and not contain fluid before the injection of fluid 84 through the side port 32. In some embodiments, in response to the injection of fluid 84 through the side port 32, the annular valve 34 may be biased against the base surface 72, and during the injection of fluid 84, it may not be necessary to allow fluid to enter the cavity 78, so that the cavity 78 becomes a dead space.

[0041] In some embodiments, the transition surface 76 may be positioned toward the terminal end 64 and / or the transition surface 76 may be positioned toward the terminal opening of the side port 32 adjacent to the lumen 30 and inner surface 28, which may facilitate the fixing of the annular valve 34 and the opening or pushing down of the proximal end 62 in response to the injection of fluid 84 through the side port 32. In some embodiments, as shown for example in Figure 3A, at least the proximal end surface 72 of the stepped surface 70 may include a rough surface, which may include sandblasting or chemical etching. In some embodiments, the rough surface is mottled in the drawings for illustrative purposes. In some embodiments, the rough surface may increase friction between the annular valve 34 and the proximal end surface 72, thereby reducing the movement of the annular valve 34.

[0042] Referring next to Figures 3E-3H, in some embodiments, the stepped surface 70 may correspond to the first stepped surface. In some embodiments, the inner surface 28 of the catheter adapter 22 may include a second stepped surface 86 at its proximal end relative to the first stepped surface. In some embodiments, the second stepped surface 86 may include a terminal surface which may correspond to the proximal end surface 72 of the stepped surface 70. In some embodiments, the second stepped surface 86 may include a proximal end surface 90 and a transition surface 92 positioned between the proximal end surface 72 and the terminal surface 74. In some embodiments, the second stepped surface 86 may be similar to or identical to the stepped surface 70 in terms of one or more features and / or operation. As shown in Figures 3E-3F compared with Figures 3G-3H, in some embodiments, the position of the first stepped surface and / or the second stepped surface 86 may vary along the inner surface 28.

[0043] In some embodiments, the transition surface 92 and the end surface of the second stepped surface 86 may merge at a sharp edge 94, which may reduce the sliding and movement of the annular valve 34. In some embodiments, the cavity 96 may be located between the outer surfaces of the annular valve 34. In some embodiments, the transition surface 92 of the second stepped surface 86 may form the end of the other cavity 94. In these embodiments, the sharp edge 94 may be in contact with the annular valve 34. In some embodiments, the sharp edge 94 may not be in contact with the annular valve 34 before injection, and a single semi-annular cavity may extend between the outer and inner surfaces 28 of the annular valve 34.

[0044] In some embodiments, the second stepped surface 86 and / or cavity 96 may be semi-annular. In some embodiments, the second stepped surface 86 and / or cavity 78 may be semi-annular. In some embodiments, in response to the injection of fluid 84 through the side port 32, the annular valve 34 may reduce the size or volume of the cavity 96. In these embodiments, the annular valve 34 may be biased toward the base surface 90 and the base surface 72. In some embodiments, in response to the injection of fluid 84 through the side port 32, the annular valve 34 may be tightened to fit the sharp edge 94, in addition to the sharp edge 82 which reduces slippage of the annular valve 34.

[0045] In some embodiments, the cavity 96 may be empty and not contain fluid before the injection of fluid 84 through the side port 32. In some embodiments, in response to the injection of fluid 84 through the side port 32, the annular valve 34 may be pressed against the base surface 90, preventing fluid from entering the cavity 96 during the injection of fluid 84, so that the cavity 96 becomes a dead space.

[0046] Referring here to Figures 3I-3J, in some embodiments, the catheter assembly 68 may include a plurality of ribs 98 extending to the end from a specific transition surface, such as the transition surface 76 and / or a second transition surface 92. In some embodiments, the ribs 98 may be radial and / or spaced along the specific transition surface. In some embodiments, the ribs 98 may be equally spaced along the specific transition surface. In some embodiments, the ribs 98 may extend along a portion of the length of the proximal end surface 72. In some embodiments, the ribs 98 may extend along less than half the total length of the proximal end surface 72. In some embodiments 15, the ribs 98 may be aligned with the longitudinal axis 83 and / or in the deforming direction.

[0047] Next, referring to Figure 3K, the base surface 72 according to several embodiments is shown from above. In some embodiments, the base surface 72 and / or the end surface 74 may be a partially cylindrical surface. In some embodiments, the base surface 72, rather than the end surface 74, may include a rough surface, which may facilitate the insertion of the annular valve 34 during manufacturing and the securing of the annular valve 34 during injection through the side port 16. In some embodiments, the base surface 72 and the end surface 74 may include a rough surface, which may facilitate the securing of the annular valve 34 during injection through the side port 16.

[0048] Next, referring to Figures 4A to 4C, catheter assemblies 100 according to several embodiments are illustrated. In some embodiments, catheter assemblies 100 may be similar to or identical to catheter assemblies 20 described with respect to Figure 2 and / or catheter assemblies 68 described with respect to Figure 3 in respect to one or more features and / or operation. In some embodiments, the inner surface 28 of the catheter adapter 22 may include one or more ridges 102, which may be arranged in a ring around the inner surface 28. In some embodiments, the inner surface 28 may include four ridges 102 or three ridges 102. In some embodiments, the inner surface 28 may include more than four ridges 102. In some embodiments, the ridges 102 may include different lengths, heights, and / or angles from each other, which may enhance the fixation of the annular valve 32 in response to injection through the side port 16. In some embodiments, the ridges 102 may include the same length, height, and / or angle from each other. In some embodiments, the inner surface 28 may include a ridge 102 not exceeding 1, which may include an annular ring.

[0049] In some embodiments, the protrusion 102 may be located at the base end and / or near the annular valve 34 within the lumen 30. In some embodiments, the protrusion 102 may be in contact with the annular valve 34. In some embodiments, the protrusion 102 may be rigid or semi-rigid. In some embodiments, the durometer of the protrusion 102 may be greater than the durometer of the annular valve 34. In some embodiments, the protrusion 102 may be formed integrally with the inner surface 28 as a single unit.

[0050] In some embodiments, the ridge 102 may be configured to hold the annular valve 34 in the same or similar position in response to fluid injection through the side port 32 that opens the annular valve 34. More specifically, in some embodiments, the ridge 102 may be configured to reduce the proximal end movement of the annular valve 34 in response to fluid injection through the side port 32 that opens the annular valve 34. In some embodiments, the proximal end 62 of the annular valve 34 does not need to move in the proximal direction in response to fluid injection through the side port 32 that opens the annular valve 34. In some embodiments, the proximal end movement of the annular valve 34 may be reduced in response to fluid injection through the side port 32 that opens the annular valve 34. Thus, in some embodiments, the ridge 102 may also prevent fluid, such as blood and / or another fluid, from leaking through the annular valve 34 from the side port 32.

[0051] Referring here to Figures 5A-5B, several embodiments of the catheter assembly 103 are shown. In some embodiments, the catheter assembly may be similar or identical in one or more features and / or functions to one or more of the catheter assembly 20 described with respect to Figure 2, the catheter assembly 68 described with respect to Figure 3, and the catheter assembly 100 described with respect to Figure 4.

[0052] In some embodiments, the inner surface 28 may include a base undercut 104 and a terminal undercut 106, and the annular valve 34 may be positioned between the base undercut 104 and the terminal undercut 106. In some embodiments, the base undercut 104 and / or the terminal undercut 106 may be annular. In some embodiments, the length of the annular valve 34 may be approximately equal to the distance between the base undercut 104 and the terminal undercut 106, and the annular valve 34 may be in contact with the base undercut 104 and the terminal undercut 106. In some embodiments, the terminal edge 48 and the base edge 50 may be annular. In some embodiments, the annular valve 34 may be tightly fitted into the base undercut 104 and the terminal undercut 106. In some embodiments, the base undercut 104 and the terminal undercut 106 may form a cavity on which the annular valve 34 may seat.

[0053] All embodiments and conditional statements incorporated herein are intended for educational purposes to help the reader understand the concepts to which the inventors have contributed to further the invention and the art, and are not limited to such specifically incorporated embodiments and conditions. While embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications may be made herein without departing from the spirit and scope of the invention.

Claims

1. It is a catheter system, A catheter assembly is provided, and the catheter assembly is A catheter adapter comprising a terminal end, a proximal end, an inner surface forming a lumen, the inner surface extending through the terminal end and the proximal end, and a side port disposed between the terminal end and the proximal end. An annular valve disposed within the lumen and aligned with the side port, wherein the annular valve seals the fluid passage from the side port to the lumen. A retaining ring or protrusion positioned at and near the proximal end of the annular valve within the lumen, and A catheter extending from the terminal end to the terminal end of the catheter adapter, A catheter system equipped with the following features.

2. The inner surface is provided with an undercut. The catheter system according to claim 1, wherein the retaining ring is positioned within the undercut.

3. The catheter system according to claim 1, wherein the inner surface comprises a proximal undercut and a terminal undercut, and the annular valve is positioned between the proximal undercut and the terminal undercut.

4. The catheter system according to claim 1, wherein the annular valve is cylindrical.

5. The catheter system according to claim 1, wherein the catheter assembly comprises the retaining ring, and the retaining ring is formed by molding.

6. The catheter system according to claim 1, wherein the catheter assembly comprises the retaining ring, and the retaining ring is made of plastic.

7. The catheter system according to claim 1, further comprising a needle assembly, the needle assembly comprising a needle hub and an introduction needle extending from the needle hub to its terminal end through the retaining ring, the annular valve, and the catheter.

8. The catheter system according to claim 1, wherein the side port extends from the top of the catheter adapter.

9. The catheter system according to claim 1, wherein the catheter assembly comprises the retaining ring, and the retaining ring is configured to reduce the proximal end movement of the annular valve in response to fluid injection through the side port opening the annular valve.

10. The catheter system according to claim 1, wherein the catheter assembly comprises the protrusion and a plurality of protrusions, and the protrusion and the plurality of protrusions are arranged in a ring shape.

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